The diagnosis of cancer in individuals has remained a difficult task to accomplish. Although some diagnostic markers are available that are assayable from blood or tissue samples, e.g. Carcinoembryonic Antigen (CEA), Alpha Fetoprotein (AFP) or Prostate Specific Antigen (PSA), the assays using these markers have not, to date, been markedly predictive of the presence of cancer in these individuals, as verified by other clinical diagnoses. The sensitivity and specificity of these assays has been disappointingly low. Time-consuming and labor-intensive clinical assessments (e.g. palpations, x-rays, mammograms, biopsies) have remained the accepted methods for diagnosing cancer. Thus, a need exists for a marker, preferably present in a biological sample, from an individual, such as blood that is predictive of the presence of cancer in the individual. In particular, a need exists for the existence of a marker and an assay to measure the presence and amount of this marker for individuals who have cancer in an early stage. If such a diagnostic test were available, early treatment with beneficial outcomes would be more likely than at present.
It is an object of this invention to provide methods for detecting the presence of primary or metastatic cancer in an individual that involves the detection of a cancer-diagnostic protein. It is also an object of this invention to provide compositions of matter that can be used to detect the presence of primary or metastatic cancer in an individual.